Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method (KIDDS)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: IUD Insertion

Treatments: Device: direct method; Device: classic method

Study type: Interventional

Funder types: Other

Identifiers

NCT03473717

HAO 180104

Details and patient eligibility

About

The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.

It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.

Full description

The classic method uses: a Pozzi for pulling the uterus to horizontalize it and a hysterometer to visualize the axis of the uterus and to measure the distance between the external orifice of the cervix and the uterine fundus in order to deploy the IUD / IUS.

In the so-called direct technique, the operator does not measure the depth of the uterus thanks to a hysterometer and does not draw the cervix with a Pozzi forceps, the IUD / IUS is deployed as soon as the orifice passes. inside the cervix and the inserter tube does not enter the uterine cavity. With this method the Pozzi forceps is only used as a second line, especially in case of a fleeing neck.

Enrollment: 158 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The study population will concern all women aged 18 to 50 who want IUD or SIU contraception regardless of whether they are nulliparous, primiparous or pluriparous, whether or not they have had an IUD or IUS.
• Having signed informed consent.
• Being affiliated to a social security scheme (excluding AME)

Exclusion criteria

• Can not express their consent
• Not mastering French
• With a contraindication to the chosen IUD or IUS.
• Having had local anesthesia of the cervix (in case of Voluntary Interruption of Pregnancy on the day of insertion)
• Having received analgesic treatment within four hours
• Patient without social security
• No consent of the patient
• Minor patient

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

classic method group

Active Comparator group

Description:

IUD/IUS insertion will be done using the conventional method

Treatment:

Device: classic method

direct method group

Active Comparator group

Description:

IUD/IUS insertion will be done using the direct method

Treatment:

Device: direct method